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Reducing the public health risks associated with reusable medical devices

May 2004

Reducing the Public Health Risks Associated With Reusable Medical Devices is a document produced by a National Coordinating Committee on Therapeutic Goods (NCCTG) <http://www.tga.gov.au/docs/html/ncctg.htm> Expert Working Group that was convened in 2003 to examine the public health issues associated with reusable medical devices that are difficult to clean, disinfect and sterilize.

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Reducing the public health risks associated with reusable medical devices (pdf,293kb)

The document discusses the issues and provides recommendations on strategies health care facilities and health authorities could adopt to improve the cleanability of reusable medical devices. The document includes in particular:

  • a review of the literature about contaminated reusable medical devices;
  • a discussion on design characteristics that create difficulties for cleaning and sterilising;
  • a discussion about the important role of central sterilizing personnel and the need for education and training;
  • guidance on issues to consider when purchasing instruments; and
  • information and suggestions about medical device incident reporting and investigation of potential breaches of infection control.

Contents

  • Disclaimer
  • Copyright
  • Acknowledgments
  • Foreword
  • The membership of the NCCTG Expert Working Group
  • Executive summary
  • Part A: Literature review - incidence of infection linked to contaminated medical devices
    1. Introduction
    2. Sterilization
    3. High Level disinfection
    4. The Creutzfeldt-Jakob Disease (CJD)
    5. Infectious disease outbreaks associated with failures of reprocessing of instruments
    6. Comments
    7. Summary
  • Part B: Factors that affect public health risks
    • B1. Instrument design
    • B2. Policies and work practices
    • B3. Manufacturer's instructions
    • B4. Purchasing decisions
  • Part C: Reporting and investigating potential breaches of infection control
    1. Introduction
    2. Adverse event reporting
    3. What to report and to whom
    4. Investigations by health care facilities
    5. Investigations by State or Territory health authorities
    6. Investigations by the TGA - Incident Report Investigation Scheme
    7. Putting the pieces together
  • References
  • Appendices
    • Appendix A: The IRIS Medical Device Incident Report Form
    • Appendix B: A checklist for purchasing reusable instruments
    • Appendix C: An example Incident Report Form for healthcare facilities
    • Appendix D: Adaptation of the NSW Health Risk Matrix Severity Assessment Code
    • Appendix E: Glossary of terms
    • Appendix F: Acronyms

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